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Manually maintained · not agency verifiedFDANov 13, 2026

bioQuad Life Sciences Issues Allergy Alert on Undeclared Milk in OsteoDenx® Dietary Supplement

Why it was recalled
Undeclared milk from cow’s-milk-derived lactoferrin. People with a milk allergy or severe sensitivity may have a serious or life-threatening allergic reaction. The announcement states that no illnesses had been reported to date.
What to do
Consumers allergic or sensitive to milk should not take the affected product and may discard it. Purchasers of the affected lots may request a full refund or replacement in corrected packaging. Check the lot and expiration date on the carton side panel; this recall covers two lots, not all OsteoDenx products.
Affected identifiers: Product | UPC | Lot | Expiration OsteoDenx® 30 capsules (17.85 g) | 8 57294 00722 8 | LOT#0524100 | 05/2027 OsteoDenx® 30 capsules (17.85 g) | 8 57294 00722 8 | LOT#0625041 | 08/2028 OsteoDenx® 60 capsules (35.7 g) | 8 57294 00734 1 | LOT#0524100 |… View all

Product | UPC | Lot | Expiration OsteoDenx® 30 capsules (17.85 g) | 8 57294 00722 8 | LOT#0524100 | 05/2027 OsteoDenx® 30 capsules (17.85 g) | 8 57294 00722 8 | LOT#0625041 | 08/2028 OsteoDenx® 60 capsules (35.7 g) | 8 57294 00734 1 | LOT#0524100 | 05/2027 OsteoDenx® 60 capsules (35.7 g) | 8 57294 00734 1 | LOT#0625041 | 08/2028

Company announcement: bioQuad Life Sciences of Yorba Linda, California is recalling two lots of OsteoDenx® dietary supplement capsules because they contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk… View all

bioQuad Life Sciences of Yorba Linda, California is recalling two lots of OsteoDenx® dietary supplement capsules because they contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume this product. The product was distributed nationwide and reached consumers through online orders at bioquad.com and Amazon.com, resellers, and a dental clinic in Redwood City, California, from November 1, 2024 to November 11, 2026. OsteoDenx® comes in a paperboard carton of 30 or 60 capsules, shown in the photos below. The lot number and expiration date are printed on the side panel of the carton. Product | UPC | Lot | Expiration ; OsteoDenx® 30 capsules (17.85 g) | 8 57294 00722 8 | LOT#0524100 | 05/2027 ; OsteoDenx® 30 capsules (17.85 g) | 8 57294 00722 8 | LOT#0625041 | 08/2028 ; OsteoDenx® 60 capsules (35.7 g) | 8 57294 00734 1 | LOT#0524100 | 05/2027 ; OsteoDenx® 60 capsules (35.7 g) | 8 57294 00734 1 | LOT#0625041 | 08/2028 No illnesses have been reported to date. The issue was identified during a routine FDA inspection. The capsules contain lactoferrin derived from cow's milk. Distribution has stopped until corrected cartons are available. Consumers who are allergic or sensitive to milk should not take the product and may discard it. Customers who purchased the affected lots may request a full refund or a replacement in corrected packaging. Consumers with questions may contact the company at (714) 660-1031, Monday to Friday, 9:30 AM to 5:00 PM Pacific Time, or [email protected]. Emails received after business hours or on weekends will be answered the next business day. This recall is being made with the knowledge of the U.S. Food and Drug Administration.

Manually maintained · not agency verifiedFDANov 13, 2026

Medline Updates Customers and Patients on Repair and Replace Program for Recall of Medline Brand Beds, Rails, Mattresses and Accessories

Why it was recalled
Potential fire hazard and entrapment risk, which may result in injury or death. As of November 8, 2026, Medline had received reports related to seven deaths and 35 serious injuries associated with these issues. These are associated reports, not a determination of causation.
What to do
Immediately unplug the bed. Plug it in only when necessary to reposition the patient, then unplug it again. Do not use extension cords; have a second person assist whenever possible. Follow Medline’s updated instructions until authorized repair or replacement. Do not attempt repairs or modifications outside a Medline-authorized process. Contact the provider or distributor; direct Medline purchasers should call 800-950-0128, option 7. Repair, replacement or full/partial refund eligibility is assessed by Medline; some options may be available for products purchased within five years.

Affected identifiers: All Medline Brand beds and associated rails, mattresses and accessories, including pendants and motor boxes. The all-brand action is not limited to the historical model lists in FDA enforcement events 98185 and 99827.

Company announcement: Medline shares new customer communication, provides instructions for continued use and additional information about options for repair, replacement and full or partial refund of original purchase price On October 14… View all

Medline shares new customer communication, provides instructions for continued use and additional information about options for repair, replacement and full or partial refund of original purchase price On October 14, 2026, Medline initiated a product recall, market exit and discontinuation of all Medline Brand beds, rails, mattresses, and accessories (e.g., pendants and motor boxes) due to a potential fire hazard and entrapment risk, which may result in patient injury or death. As of November 8, 2026, Medline has received reports related to seven deaths and 35 serious injuries associated with these issues. Background Medline distributed the Medline Brand beds, rails, mattresses and accessories in the United States and Canada between 2011 and 2026 to Durable Medical Equipment providers, long-term care facilities, and end users directly. The recall includes all Medline Brand beds, and associated rails, mattresses, and accessories on the market; details can be found here: https://www.medline.com/pages/product-recalls/medline-bedaccessories/. Instructions for Consumers On October 14, 2026, Medline began notifying their customers of the recall via letter. Medline issued updated letters on October 24, 2026, providing customers updated instructions for continued use and options for repair, replacement and full or partial refund of original purchase price. Instructions for continued use are as follows: The recalled beds may remain in use in accordance with the updated instructions, as follows, until the bed is either repaired or replaced. Immediately unplug the beds from electrical outlets. When necessary adjustments to the bed need to be made, plug the bed into an electrical outlet while repositioning the patient and unplug the bed when not repositioning the patient. Do not use extension cords to power the bed. Whenever possible, have a second person available to assist with the use and movement of the bed. Medline will soon begin distributing new repair and replace Customer Guides to patients and users of all relevant Medline Brand beds, rails, mattresses and accessories, in line with previous updates. These visual guides, along with identifying product SKUs and customer label instructions, will be found at this website: https://www.medline.com/pages/product-recalls/medline-bed-accessories/. Information about the repair and replace program is as follows: Certain existing Medline Brand beds may be eligible for repair. Beds that are repaired may then be used in accordance with their Instructions for Use. If Medline determines that beds and accessories are not eligible for repair, Medline will work with customers to determine their eligibility for applicable replacement or full or partial refund of the original purchase price. NOTE: Repair, replacement, or full or partial refund of the original purchase price may be available for certain beds, rails, mattresses, and accessories purchased in the last five years. NOTE: Do not attempt to repair, modify, or alter Medline Brand beds unless specifically instructed by Medline through a Medline-authorized repair process. To determine your eligibility, contact the provider or distributor from whom you purchased or received the bed. If you purchased your bed directly from Medline, please contact Medline Recall Customer Service at 800-950-0128, option 7. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online: www.fda.gov/medwatch/report.htm Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. Customers with questions may contact the company by contacting Medline Recall Customer Service at 1-800-950-0128, option 7, between the hours of 8:00am and 5:00pm CT, Monday through Friday. Customers may also contact the company via e-mail at [email protected].

CPSCNov 12, 2026

Allstar Recalls Sharper Image Tabletop and Infinity Fire Pits Due to Risk of Serious Injury from Burn and Fire Hazards

Why it was recalled
Ignited flammable liquid can escape from the recalled fire pits or trigger flame jetting from the fuel containers, posing a risk of serious injury from burn and fire hazards.
What to do
Consumers should stop using the recalled fire pits immediately and contact Allstar for a full refund. Consumers will be asked to register at www.firepitrecall.expertinquiry.com, write “RECALLED – DO NOT USE” in permanent marker, and submit three photographs following the instructions on Allstar’s recall page. After registration is confirmed, consumers should dispose of any remaining fuel in accordance with local hazardous-waste requirements and discard the recalled fire pits safely.

Affected identifiers: Sharper Image Tabletop Fire Pits and Sharper Image Tabletop Infinity Fire Pits

Firm / distribution: This recall involves outdoor Sharper Image-Branded Tabletop Fire Pits and Sharper Image-Branded Tabletop Infinity Fire Pits. The units have a “77” logo on the front, a Lot Code sticker in the center of the base, a round… View all

This recall involves outdoor Sharper Image-Branded Tabletop Fire Pits and Sharper Image-Branded Tabletop Infinity Fire Pits. The units have a “77” logo on the front, a Lot Code sticker in the center of the base, a round black sticker marked “CHINA” with a 5-digit code, the letters KS-CY or KS-FC, and a date code in YYYY-MM-DD format. The Sharper Image-Branded Tabletop Fire Pits feature a small cylindrical concrete body with a removable snuffing lid and an open burn chamber at the top. The Sharper Image-Branded Tabletop Infinity Fire Pits feature a steel base and tempered‑glass side panels.

CPSCNov 12, 2026

SHEIN Distribution Corporation Recalls Baby Rattle and Teether Toy Sets Due to Risk of Serious Injury or Death from Choking; Violate Mandatory Small Parts Ban

Why it was recalled
The recalled toy sets violate the small parts ban because they are intended for children under three years old and the purple and orange knobs can detach from the product, posing a deadly choking hazard to young children.
What to do
Consumers should stop using the recalled toy sets immediately, take them away from children, and contact SHEIN for a refund. Consumers will be asked to affirm they disposed of the toy sets to receive a refund.

Affected identifiers: Baby Rattle and Teether Toy Sets

Firm / distribution: This recall involves Baby Rattle and Teether Toy Sets. The sets include seven toys in a variety of pastel colors and shapes. SKU “sk25070936134444119” is located on the upper right corner of a label on the product… View all

This recall involves Baby Rattle and Teether Toy Sets. The sets include seven toys in a variety of pastel colors and shapes. SKU “sk25070936134444119” is located on the upper right corner of a label on the product packaging.

CPSCNov 12, 2026

QIOMALA Pressure Washers Recalled Due to Serious Risk of Injury or Death from Shock and Electrocution Hazards

Why it was recalled
The recalled pressure washers lack an adequate-length power cord, which can encourage use of an extension cord, posing a serious risk of injury or death from shock and electrocution hazards.
What to do
Consumers should stop using the recalled pressure washers immediately and contact QIOMALA for a full refund. Consumers will be asked to unplug the pressure washer, cut the power cord in half and send a photo of the destroyed power washer, showing the model number, to [email protected]. Consumers should then dispose of the destroyed recalled product.

Affected identifiers: QIOMALA Pressure Washers

Firm / distribution: This recall involves QIOMALA-branded pressure washers with model number “HWT12P”. The 1.2 GPM electric pressure washers were sold in green with black and in blue with black and measure about 14 inches deep, 11 inches… View all

This recall involves QIOMALA-branded pressure washers with model number “HWT12P”. The 1.2 GPM electric pressure washers were sold in green with black and in blue with black and measure about 14 inches deep, 11 inches wide and 15 inches high. The pressure washers came with a 500 ml soap tank, four quick disconnect nozzles and a 20-foot hose. Model number “HWT12P” is printed on a label on back of the unit, near the power cord entry point.

CPSCNov 12, 2026

Kakgold Recalls 4WD Remote-Controlled Car Toys Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Toys

Why it was recalled
The recalled remote-controlled cars violate the mandatory standard for toys because they contain button cell and lithium-ion batteries in the remote control that can be easily accessed by children, posing a deadly ingestion hazard to children. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death
What to do
Consumers should stop using the remote-controlled car toys immediately and contact Kakgold for information on how to receive a full refund. Consumers will be asked to write “RECALLED” on the product and email a photograph showing the product being properly disposed of in the trash to [email protected]. Note: Button cell batteries are hazardous. Batteries should be disposed of or recycled by following local hazardous waste procedures.

Affected identifiers: Kakgold 4WD Stunt Vehicle Toys

Firm / distribution: This recall involves the Kakgold 4WD stunt vehicles with a remote-control containing button cell and lithium-ion batteries. The toy car has a lime green and blue body, a black chassis and four black wheels with lime… View all

This recall involves the Kakgold 4WD stunt vehicles with a remote-control containing button cell and lithium-ion batteries. The toy car has a lime green and blue body, a black chassis and four black wheels with lime green trim and diagonal rollers. The vehicle body features checkered patterns, an “X” design and the words “PRO” and “RACING.” A white hang tag attached to the vehicle body displays “Do Not Twist the Shaft” in red lettering and illustrations marked with red crosses.

CPSCNov 12, 2026

Huffy Recalls Buzz Bicycles Cerana T2 E-Trikes Due to Risk of Serious Injury from Fall Hazard

Why it was recalled
The recalled tricycles’ rear wheels can become loose or separate from the rear frame, posing a risk of serious injury from a fall hazard.
What to do
Consumers should stop using the recalled tricycles immediately and contact Huffy for free replacement rear axle assemblies. The rear wheel axle assemblies will be sent directly to consumers or to a third-party who will repair the tricycle. Huffy Corporation will reimburse consumers up to $100 for charges incurred by the third-party repair.

Affected identifiers: Buzz Bicycles Cerana T2 E-Trike

Firm / distribution: This recall involves Buzz Bicycles Cerana T2 E-Trike, model E4004. The tricycle is a pedal assist tricycle. The tricycle is gray with "BUZZ" logos on the left and right side. The tricycle has a 500-Watt motor and a… View all

This recall involves Buzz Bicycles Cerana T2 E-Trike, model E4004. The tricycle is a pedal assist tricycle. The tricycle is gray with "BUZZ" logos on the left and right side. The tricycle has a 500-Watt motor and a 48-Volt battery. The tricycle has three 24-inch wheels. The model number is printed on a label near the pedals on the bottom side of the frame’s downtube.

CPSCNov 12, 2026

Cummins Recalls Portable Generators Due to Risk of Serious Injury from Fire and Burn Hazards

Why it was recalled
The valves in the recalled generators were installed incorrectly, preventing fuel vapors from venting properly from the gasoline tank, causing excessive pressure to build up. This pressure can cause fuel to discharge or the fuel cap to eject, posing a risk of serious injury from fire and burn hazards.
What to do
Consumers should stop using the recalled portable generators immediately and go to https://www.cummins.com/en-na/na/generators/portable-generators/safety-recalls/campaigns/7308 to check if the model and part number is included in the recall. If your unit is affected, contact an authorized Cummins service location and arrange for a free repair at the service location. To find a service location near you, please use the Service Locator link at https://quickserve.cummins.com.

Affected identifiers: Cummins Onan P5000iDF EFI Dual Fuel Portable Generators

Firm / distribution: This recall involves the Cummins Onan P5000iDF EFI Dual Fuel Portable Generators sold in a dark gray color. The generators can operate on gasoline or propane, and produce between 4,500 and 5,000 watts, depending on fuel.… View all

This recall involves the Cummins Onan P5000iDF EFI Dual Fuel Portable Generators sold in a dark gray color. The generators can operate on gasoline or propane, and produce between 4,500 and 5,000 watts, depending on fuel. “Cummins” is printed in white on the front of the unit and the handle above the control panel. The Cummins "C" logo and "Onan P5000iDF EFI" are printed on the side. The model and part number can be found on the label attached to the side of the generator.

CPSCNov 12, 2026

Boshengya Recalls Rugs Due to Risk of Serious Injury or Death from Fire Hazard; Violate Mandatory Standard for Carpets and Rugs

Why it was recalled
The recalled rugs violate the mandatory standard for the flammability of carpets and rugs, posing a risk of serious injury or death from fire hazard.
What to do
Consumers should stop using the rugs immediately and contact Boshengya for a full refund. Consumers will be asked to destroy the rug by cutting it in half and send a photo of the destroyed rug to [email protected]. Consumers will then dispose of the recalled product.

Affected identifiers: Boshengya Shag Area Rugs

Firm / distribution: This recall involves Boshengya-branded rugs. The pink or orange shag area rugs measure about 5 or 6 feet wide and 8 feet long. ‘INCREDIBLY SOFT’ is printed on a label on the product packaging.

CPSCNov 12, 2026

CPSC Warns Consumers to Stop Using Bambora Sling Carriers Immediately Due to Risk of Serious Injury or Death from Fall Hazard; Violate Mandatory Standard for Sling Carriers

Why it was recalled
The Bambora Sling Carriers violate the mandatory safety standard for sling carriers because the restraint strap can fail causing it to come apart, posing a deadly fall hazard to babies.
What to do
CPSC urges consumers to stop using the sling carriers immediately, cut the fabric in half to make the product unusable and then dispose of the product. Do not sell or give away these hazardous products.

Affected identifiers: Bambora Sling Carriers

Firm / distribution: The U.S. Consumer Product Safety Commission (CPSC) is warning consumers to stop using the Bambora Sling Carriers immediately because the restraint strap can fail causing it to come apart, posing a deadly fall hazard to… View all

The U.S. Consumer Product Safety Commission (CPSC) is warning consumers to stop using the Bambora Sling Carriers immediately because the restraint strap can fail causing it to come apart, posing a deadly fall hazard to babies. CPSC urges consumers to stop using the sling carriers immediately, cut the fabric in half to make the product unusable and then dispose of the product. Do not sell or give away these hazardous products. CPSC issued a Notice of Violation to Bambora. Bambora has not responded to the Notice of Violation. This warning involves Bambora sling carriers. The carriers come in several prints and include an adjustable black strap. “Bambora” and “Bambora Sling Carrier” are printed on a label stitched on the end of the strap.

FDANov 12, 2026

Game Changer Products LLC Issues Voluntary Nationwide Recall of 10 Day Forecast Capsules Due to the Presence of Undeclared Sildenafil and Acetaminophen

Why it was recalled
Tainted with Sildenafil and Acetaminophen
What to do
Follow the company's instructions in the official FDA announcement.

Affected identifiers: 10 Day Forecast Capsules 3200mg

Company announcement: FOR IMMEDIATE RELEASE – November 12, 2026 - Tampa, Florida. Game Changer Products LLC is voluntarily recalling all lots of 10 Day Forecast capsules to the consumer level. FDA analysis has found the product to be tainted… View all

FOR IMMEDIATE RELEASE – November 12, 2026 - Tampa, Florida. Game Changer Products LLC is voluntarily recalling all lots of 10 Day Forecast capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil and acetaminophen. Sildenafil is an active ingredient in an FDA-approved prescription drug product, used to treat erectile dysfunction. Acetaminophen is a prescription and over-the-counter drug product used to temporarily relieve pain and reduce fever. Products containing sildenafil and acetaminophen cannot be marketed as dietary supplements. 10 Day Forecast capsules are unapproved new drugs for which safety and efficacy have not been established and, therefore, subject to recall. Risk Statement: Consumption of products with undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population, who are most likely to use this product, those who use nitrates for cardiac conditions are most at risk. For patients already consuming acetaminophen products, unknowingly consuming additional acetaminophen, may result in life-threatening adverse events including liver damage, ranging from mild liver problems to complete liver failure and death, anaphylaxis and serious skin reactions. To date, Game Changer Products LLC has not received any reports of adverse events related to this recall. The tainted 10 Day Forecast capsules are marketed as a male sexual enhancement product and is packaged as capsules in cards of 1 to 2 blue capsules, UPC 191645852717. All lots and expiration dates are included in this recall. The lot number and expiration date are printed on the back of each card. The packaging may be identified by its black background with white lettering. Game Changer Products LLC, sold 10 Day Forecast nationwide, including Puerto Rico, Guam and the Northern Mariana Islands, through its website, gamechangerproductsllc.com, and on eBay, and to one retail store in Minnesota, from at least October 2021 through October 17, 2026. Game Changer Products LLC is notifying its customers by e-mail, through eBay’s messaging system, and is notifying the retail store by letter. Consumers who have 10 Day Forecast should stop using it and throw away any unused product in a safe manner. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this product. Consumers with questions regarding this recall can contact Game Changer Products LLC at 813-419-7033 or [email protected], Monday through Friday, 9 a.m. to 6 p.m., Eastern Time. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report online: www.fda.gov/medwatch/report.htm Regular mail or fax: Download the form at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Media contact: Benjamin H. Lindsey, Game Changer Products LLC, 813-419-7033, [email protected]

FDANov 12, 2026

Eros Apothecary Issues Recall of Candy Power For Man Organic Honey Due to Undeclared Tadalafil

Why it was recalled
Contain Undeclared Tadalafil
What to do
Follow the company's instructions in the official FDA announcement.

Affected identifiers: Honey Dietary Supplement

Company announcement: Eros Apothecary of Indio, California is recalling Candy Power For Man Organic Honey because the product was found to contain undeclared tadalafil. Tadalafil is the active ingredient in the FDA-approved prescription drug… View all

Eros Apothecary of Indio, California is recalling Candy Power For Man Organic Honey because the product was found to contain undeclared tadalafil. Tadalafil is the active ingredient in the FDA-approved prescription drug Cialis, used to treat erectile dysfunction. FDA approval of Cialis is restricted to use under the supervision of a licensed health care professional. The undeclared tadalafil may interact with nitrates found in certain prescription medications, such as nitroglycerin, and cause a dangerous drop in blood pressure. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrate-containing medications. The product was sold via eBay between April 27, 2026, and July 20, 2026. The Candy Power For Man Organic Honey is packaged in yellow and orange packaging, containing 60 individually wrapped candies. The following identifying information appears on the back panel of the product packaging: Batch: 241020 Manufacturing Date: January 2024 Expiration Date: December 2029 UPC: 5285002251390 The recall was initiated after FDA laboratory testing identified undeclared tadalafil. Consumers should stop using Candy Power For Man immediately and dispose of any remaining product. Consumers with questions regarding this recall may contact Eros Apothecary at [email protected] Consumers who have experienced health problems potentially related to this product should contact their healthcare provider. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report: Online: www.fda.gov/medwatch/report.htm Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Manually maintained · not agency verifiedFDANov 12, 2026

Luna G3 BPAP System LG3800-30VT — Class I recall for Targeted VT pressure-recording error

Why it was recalled
When Targeted VT is enabled, the configured IPAP value is recorded and transmitted instead of the actual delivered inspiratory pressure. This does not establish that the delivered pressure itself is incorrect. FDA classification: Class I; cause: device design. Incident and injury counts are not disclosed in this record.
What to do
Immediately discontinue Targeted VT if enabled on affected devices. Remove affected devices from clinical service and segregate them to prevent further use; use unaffected PAP devices for patient support. Complete the customer response form included with the notification letter to receive the React Health firmware correction, then update as directed. Customer notifications began October 9, 2026.

Affected identifiers: Luna G3 BPAP System for treatment of adult obstructive sleep apnea. Match the individual serial number against FDA Code Information; model alone does not establish inclusion.

Firm / distribution: FDA posted this Class I recall on November 12, 2026. The firm initiated the action on October 8, 2026 and began notifying customers on October 9, 2026. FDA status at review: Open, Classified. Official source checked… View all

FDA posted this Class I recall on November 12, 2026. The firm initiated the action on October 8, 2026 and began notifying customers on October 9, 2026. FDA status at review: Open, Classified. Official source checked November 13, 2026 UTC: FDA CDRH cfRES record 223102, Event 100001, Z-0409-2027. The official notice contains a long affected-serial-number list; consult that list and the notification letter to identify an individual device. The record does not disclose injury or death counts. A specific event revision timestamp is not disclosed.

Manually maintained · not agency verifiedFDANov 12, 2026

Securitas Arial Call Stations: Batteries May Deplete Without Low-Battery Alert

Why it was recalled
Call station batteries may fully deplete without a low-battery alert. FDA Class II; cause remains under investigation by the firm. Injury counts and actual call failures are not disclosed in this record.
What to do
Replace installed or stock Panasonic/non-approved batteries with Duracell, Jauch or GP CR123 batteries. Reduce Missing Device Timeout to 125 minutes following the firm notice appendix; this may give earlier notification on some systems. Regularly monitor alerts and battery status, investigate Missing Device alerts promptly, and implement supplemental safeguards for high-risk residents. Firm website notice: October 12, 2026; customer letters: October 22, 2026.

Affected identifiers: Arial Call Stations, firmware V1.6.4

Manually maintained · not agency verifiedFDANov 12, 2026

Tandem Mobi Android App Correction: Extended Bolus Immediate Dose May Be Omitted

Why it was recalled
When the entered glucose value equals the active target, the Now portion of an Extended Bolus is incorrectly reduced to zero. The Later portion is delivered, but total insulin may be lower than intended without a distinct alert, potentially causing unrecognized under-delivery and hyperglycemia. FDA Class II; injury counts not disclosed.
What to do
Android users: do not use Extended Bolus. Standard Bolus and other available functions may still be used. Share the notice with caregivers and acknowledge receipt using the notification link or QR code. This is not an instruction to stop using the pump. Correction emailed October 13, 2026.

Affected identifiers: Tandem Mobi Insulin Pump with Interoperable Technology, with Android Tandem Mobi Mobile app

FDANov 10, 2026

Laub's Feeding & Cubing, Inc. Voluntary Recalls Grade A Mini Hay Cubes Because of Potential Clostridium Botulinum Contamination

Why it was recalled
Potential to be contaminated with Clostridium Botulinum
What to do
Follow the company's instructions in the official FDA announcement.

Affected identifiers: Grade A Mini Hay Cubes

Company announcement: Laub’s Feeding and Cubing, Inc. of Beryl, Utah is voluntary recalling up 89 ton of Grade A Mini Hay Cubes sold from October 3 – October 31 because the product has the potential to be contaminated with Clostridium… View all

Laub’s Feeding and Cubing, Inc. of Beryl, Utah is voluntary recalling up 89 ton of Grade A Mini Hay Cubes sold from October 3 – October 31 because the product has the potential to be contaminated with Clostridium botulinum, a bacterium that can cause botulism, leading to severe and potentially fatal toxicity in animals that consume contaminated food. Common symptoms may include muscle weakness, muscle tremors, difficulty vocalizing or swallowing, loss of muscle tone such as “floppy tail”, weak eyelids, flaccid tongue, trouble breathing, abdominal distension, colic, constipation, and inability to urinate. Animals experiencing any of these symptoms should receive immediate veterinary attention. Product was sold at the Paragonah Farm, Paragonah, Utah or at the Feed Store in St. George, Utah, in October 2026. After initial distribution, some customers may have further distributed the product to additional locations or recipients. Distribution of the Grade A Mini Hay Cubes could include Utah, Northern Arizona, Nevada and Southern California. Laub’s Feeding and Cubing, Inc. began notifying customers of the recall via direct contact on November 3. The Grade A Mini Hay Cubes were sold in 1500 lb totes and in bulk supply. This recall was initiated after the Utah Department of Agriculture and Food (UDAF) received recent reports of illness and death in horses in southern Utah and surrounding areas. UDAF officials received initial reports of several horses on one farm becoming sick, three of which had died. Additional reports were then received on Nov. 2. of other horses also being impacted in southern Utah, Nevada and Arizona. The cause of the deaths is currently unconfirmed, but testing of feed cubes sold at facilities in southern Utah is underway to identify an exact cause. Illnesses and deaths in horses were reported; however, the number of illnesses have not been confirmed. Customers who have the recalled Grade A Mini Hay Cubes should not feed the product to their animals and are encouraged to return the product to the place of origin. If not returned, quarantine the product in a secure covered location inaccessible to animals and contact the company for further instructions. Horse owners should immediately contact their local veterinarian if their horse exhibits neurologic signs, which may include depression, colic or incoordination. Reports of adverse events should be reported here: https://www.fda.gov/animal-veterinary/report-problem/reporting-problems-horse-or-other-livestock-feedfood Customers with questions may contact the company at 1-435-439-5531 Monday through Friday from 8 am to 5 pm MST.

FDANov 10, 2026

Family Farmstead Dairy Announces Recall of All Cheddar Cheese Products Because of Possible Health Risk

Why it was recalled
Potential to be contaminated with Listeria monocytogenes.
What to do
Follow the company's instructions in the official FDA announcement.

Affected identifiers: Product Description | Lot Code/Best By Date Raw Mild Cheddar, 8oz, plastic wrapped | All lot codes dated 10/16/27 and prior Raw Sharp Cheddar, 8oz, plastic wrapped | All lot codes dated 10/16/27 and prior

Company announcement: Worcester, New York – Family Farmstead Dairy is recalling all cheddar cheese products because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal… View all

Worcester, New York – Family Farmstead Dairy is recalling all cheddar cheese products because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. This decision follows the company's October 15, 2026 recall of certain raw cheddar products due to potential contamination with E. Coli O26:H11 and O45:H2 Product was distributed in NY, NJ, VT, NH, MA, PA, RI, CT, DE, VA, WV, and TN through retail stores. Products Affected Product Description | Lot Code/Best By Date ; Raw Mild Cheddar, 8oz, plastic wrapped | All lot codes dated 10/16/27 and prior ; Raw Sharp Cheddar, 8oz, plastic wrapped | All lot codes dated 10/16/27 and prior No other Family Farmstead Dairy products are included in this recall unless specifically identified by the company. Consumer Information Consumers who have purchased affected cheddar products may return them to the place of purchase or contact Family Farmstead Dairy directly for assistance. This action is being taken as part of our ongoing commitment to continuous improvement and product excellence. Due to the potential of contamination, all Cheddar products with an expiration date of 10/16/27 and prior is being recalled at this time. Questions regarding this recall may be directed to: Family Farmstead Dairy Phone: (607) 397-4044 (M-F, 8:00-5:00) Email: [email protected] Family Farmstead Dairy appreciates the cooperation of its distributors, retailers, and customers and apologizes for any inconvenience this action may cause. The company remains committed to producing safe, high-quality dairy products and maintaining the trust of the communities it serves. About Family Farmstead Dairy Family Farmstead Dairy is committed to producing high-quality dairy products while maintaining rigorous standards for food safety, product quality, and continuous improvement throughout its operations.

FDANov 9, 2026

Eugia US LLC (f/k/a Auro Medics Pharma LLC) Issues Voluntary Nationwide Recall of Vancomycin Hydrochloride for Injection USP 1.25g/Vial-30mL (Single Dose Vial) Due to Presence of Particulate Matter

Why it was recalled
Presence of particulate matter identified as a glass particle inside the vial
What to do
Follow the company's instructions in the official FDA announcement.

Affected identifiers: Vancomycin Hydrochloride for Injection USP 1.25g/Vial-30mL (Single Dose Vial)

Company announcement: November 06,2026 – East Windsor, New Jersey, Eugia US LLC (f/k/a Auro Medics Pharma LLC) is voluntarily recalling lot number 3VM26026A of Vancomycin Hydrochloride for Injection USP 1.25g/Vial-30mL (Single Dose Vial) to… View all

November 06,2026 – East Windsor, New Jersey, Eugia US LLC (f/k/a Auro Medics Pharma LLC) is voluntarily recalling lot number 3VM26026A of Vancomycin Hydrochloride for Injection USP 1.25g/Vial-30mL (Single Dose Vial) to the hospital/healthcare facility/user level due to the presence of particulate matter identified as a glass particle inside the vial. Risk Statement: There is a reasonable probability that use of product containing glass particulates can cause serious adverse health consequences such as blockage and clotting in blood vessels, which can cut off blood flow to vital organs, lead to a life-threatening blood clot in the lungs (pulmonary embolism) and cause permanent organ damage or death. Additionally, these particles may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, and allergic reactions. Greater susceptibility may exist in neonates, infants and patients with compromised organ function. To date, Eugia US LLC has not received any reports of adverse events related to this recall. Vancomycin hydrochloride for injection is a glycopeptide antibacterial indicated in adult and pediatric patients (Neonates and Older) for the treatment of Septicaemia, Infective Endocarditis, Skin and Skin Structure Infections, Bone Infections and Lower Respiratory Tract Infections. The recalled product is packaged in 30 mL vial and packed as 10 (vials) X 10 (Printed cartons) X 01 (Shipper) with NDC code as 55150-471-01. The product can be identified by product name on carton (NDC 55150-471-10) and vial (NDC 55150-471-01) label and with lot number 3VM26026A and Exp. JUL 2028 Eugia US LLC shipped the entire lot to wholesalers nationwide from September 2, 2026, through September 15, 2026. The Company is notifying its distributors and customers by recall letters and is arranging for return/replacement of all recalled products. Wholesalers/hospitals/pharmacies, institutions, and doctors with existing inventory of the recalled product lot should discontinue use and quarantine the product immediately. If you have further distributed the recalled product lot, please notify your accounts and or any additional locations which may have received the recalled product. Hospitals and institutions should inform Healthcare professionals in your organization of this recall. Consumers with medical questions regarding this recall or reporting an adverse event can contact Eugia US LLC from 8:00 am to 5:00 p.m. (EST) Monday to Friday at: 1-866-850-2876 Option 2 [email protected] Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. If you have any general questions regarding the return of this product, please contact Qualanex at 1-800-505-9291 or email [email protected] (live calls received 7:00 am to 4:00 pm M-F CST). Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online: www.fda.gov/medwatch/report.htm Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

FDANov 8, 2026

Fresh & Ready Foods LLC Recalls Fresh To You Brand Sausage, Egg & Cheese Biscuit Sandwich due to Possible Health Risk

Why it was recalled
Potential to be contaminated with Listeria monocytogenes.
What to do
Follow the company's instructions in the official FDA announcement.

Affected identifiers: PRODUCT | SKU & UPC | USE BY / GOOD THRU DATES | WHERE DATE CAN BE FOUND Fresh to You Sausage, Egg & Cheese Biscuit Sandwich.4.6 oz packaged in clear plastic film | SKU 3100048 UPC 8 405493 0168 4 | Fresh Thru: 11/07-11/19 | Front label

Company announcement: November 7, 2026, Fresh & Ready Foods LLC of Renton, WA is recalling 2,414 of Fresh To You Sausage, Egg & Cheese Biscuit Sandwiches (4.6 oz) because it has the potential to be contaminated with Listeria monocytogenes, an… View all

November 7, 2026, Fresh & Ready Foods LLC of Renton, WA is recalling 2,414 of Fresh To You Sausage, Egg & Cheese Biscuit Sandwiches (4.6 oz) because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea. Listeria monocytogenes infection can cause miscarriages and stillbirths among pregnant women. The recalled Fresh To You Sausage, Egg & Cheese Biscuit Sandwiches were produced at a Fresh & Ready facility in Renton, Washington and was distributed in Oregon and Washington to employee break rooms, refrigerated vending, and cafeterias between October 25 and November 4, 2026. This recall is in connection with a recall initiated by CH Guenther & Son for certain biscuit products that may be contaminated with Listeria monocytogenes. Fresh & Ready Foods used the affected biscuit as an ingredient only in the specific product listed below. PRODUCT | SKU & UPC | USE BY / GOOD THRU DATES | WHERE DATE CAN BE FOUND ; Fresh to You Sausage, Egg & Cheese Biscuit Sandwich.4.6 oz packaged in clear plastic film | SKU 3100048 UPC 8 405493 0168 4 | Fresh Thru: 11/07-11/19 | Front label No other Fresh To You or Fresh & Ready Foods products, production dates, or products manufactured at other Fresh & Ready facilities are impacted. No illnesses have been reported to date. Consumers who have purchased the affected product are urged not to consume the product and discard any remaining product immediately. Consumers with questions or who would like to request a full refund may contact Fresh & Ready Foods by email at [email protected] or by calling 1-855-424-8390, Monday through Friday, 8:00 a.m. to 6:00 p.m. ET.

Class IIFDANov 4, 2026

Blue Bottle Coffee 4oz Sweet Blossom Simple Syrup in a glass boston round bottle with metal and plastisol cap. The label reads in part as "***BLUE…

Why it was recalled
Potential contamination with mold (Aspergillus niger)
What to do
The recall is ongoing. Follow the firm and FDA instructions.
Affected identifiers: UPC: 810123980659 Batch information: 4ozBBCSB261051, Expiration Date: 04/15/2028 4ozBBCSB261061, Expiration Date: 04/16/2028 4ozBBCSB261071, Expiration Date: 04/17/2028 4ozBBCSB261181, Expiration Date: 04/28/2026 4ozBBCSB261201, Expiration Date: 04/30/2028… View all

UPC: 810123980659 Batch information: 4ozBBCSB261051, Expiration Date: 04/15/2028 4ozBBCSB261061, Expiration Date: 04/16/2028 4ozBBCSB261071, Expiration Date: 04/17/2028 4ozBBCSB261181, Expiration Date: 04/28/2026 4ozBBCSB261201, Expiration Date: 04/30/2028 4ozBBCSB261281, Expiration Date: 05/08/2028 — 9420 bottles

Firm / distribution: Pink House Alchemy, LLC — Sole consignee: Blue Bottle Coffee LLC, 476 9th Steet Oakland, CA 94607